- Provides overall direction and leadership of the Site Quality System by: assuring good manufacturing practice compliance for plant, laboratory operations, and manufacturing records (includes systems for CAPA, exceptions, document management, complaint handling, supplier quality, OOS investigations, stability programs, and regulatory inspection readiness); assuring finished product quality; assuring proper use of raw materials; directing sampling and inspection of raw materials and finished products; and by auditing the components to ensure that they operate in accordance with established procedures and regulatory requirements.
- Ensures FDA, EU, and International Regulatory inspection readiness through the development of compliance enhancement plans, internal audit programs, and industry intelligence.
- Manages the customer complaint program, including interaction with customers and resolution of critical issues.
- Manages the supplier quality program to fulfill regulatory and site needs.
- Conducts and/or administers new employee, ongoing, and directed training on GMP topics to ensure compliance to regulations.
- Manages the CAPA program to effectively identify and correct problems that affect product quality or compliance.
- Manages all validation activities for new, altered, or modified equipment, facilities, or manufacturing processes.
- Manages the customer audit process (approximately 20/yr.) to include preparation, hosting, and responding to issues noted - also, utilize input from customer audits as a continuous improvement tool.
- Documents management and label control to fulfill regulatory and business needs.
- Administers the stability program for both API and intermediate drug products manufactured at the site.
- Approves highly technical investigations involving product impact.
- Sets direction and policies for cGMP compliance activities.
- Schedules employees, performance appraisals, and performance management of team members.
- Budgets and adherence for areas of functional responsibility.
- Direct interaction with key customers relating to technical issues, potential non-compliance activities, or service issues impacted by quality/compliance.
- Resolution of critical quality issues that could affect production, customer service, quality, or compliance.
- Interprets regulatory guidance to determine site course of action for compliance.
- Technical expert in multiple quality functional areas, such as validation, product investigations, quality systems, and establishing compliance plans, etc.
- Minimum of 7-10 years of pharmacuetical industry experience in a Quality Assurance function including experience in manufacturing and control of bulk drug substances or solid dosage form drug products.
- Minimum of 5 years managerial experience in a pharmaceutial quality organization with proven leadership over high performing teams.
- Working knowledge of chemical, pharmaceutical or bio-pharmaceutical manufacturing.
- Strong knowledge of FDA and International regulations and guidances in the area of Quality Systems for pharmaceutical products.
- Exceptional oral and written communication skills. Strong managerial and excellent negotiating skills in order to obtain balanced results from direct and indirect reports.
- Experience interacting with regulatory agencies such as the FDA and EU regulatory bodies as an inspection host or area subject matter expert.
- Strong patient and customer focus.
- Strong writing skills to effectively communicate technical/clinical information to others.
- Ability to use various software programs (Word, Excel, Power Point, Access) and a willingness to expand and increase these competencies.
- Superior verbal communication skills including impeccable telephone etiquette.
- Scientific literature searching and evaluation skills.
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Manager Plant Quality - Greenville, United States - Mallinckrodt
Description
Job TitleManager Plant Quality
Requisition
JR Manager Plant Quality (Open)
Location
Greenville, IL (Pharma) - USA034
Additional Locations
Greenville, IL
Job Description
SUMMARY OF POSITION:
The Manager Plant Quality II directs the operation of the Greenville Quality Department to ensure product quality and regulatory compliance. The Quality Manager will champion the continued transformation of the Greenville Site to pharmaceutical finished drug product standards while achieving stated departmental and business objectives. The Quality Manager will operate the Site Quality System by evaluating, analyzing, and reporting on product and process quality performance and GMP compliance. S/he will exercises full autonomy for determination of key compliance activities and administration of Quality Systems to meet regulatory, plant, or customer needs and serve as the final Quality contact for decisions of functional responsibility.
ESSENTIAL FUNCTIONS:
Education:
Bachelor's degree in chemistry, microbiology or similar life sciences or technical field
Experience:
This Position works primarily in an office environment. Ability to sit for long periods of time and lifting of up to 10 pounds may occasionally be required. Will require occasional periods in the manufacturing areas and walking throughout the plants. Manufacturing areas are not climate controlled. During summer months, building exhaust fans provide ventilation but remain warm. When in manufacturing areas, PPE is required to be worn.
Approximately 10 to 15% travel (mainly domestic, but some international) will be required for manufacturing site visits and off-site business meetings and professiona training seminars and conference.
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
